Tag: FDA approval process

FDA approval process

Regulatory/FDA

COVID-19 Pandemic Likely to Affect FDA Product Approval Timelines

COVID-19 Pandemic Likely to Affect FDA Product Approval Timelines

April 27, 2020 – As the COVID-19 pandemic continues, the Food and Drug Administration (FDA) must balance safeguarding public health with the desire for timely product reviews. Staff members at the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are working diligently to keep all of these balls in […]

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Regulatory/FDA

FDA Streamlines COVID-19 Product Pathways, Continues to Crack Down on Misleading Claims

FDA Streamlines COVID-19 Product Pathways, Continues to Crack Down on Misleading Claims

April 13, 2020 – The Food and Drug Administration (FDA) is responding to the challenges of COVID-19 in new ways that streamline product review and policy approaches, while also ensuring that entities promoting unapproved products that claim to be effective against the virus do not go unchecked. Last week, the FDA and the Federal Trade […]

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Regulatory/FDA

FDA’s Second Half: Org Changes, Updating Trial Design and Promotional Regulation, 2020 Budget

FDA’s Second Half: Org Changes, Updating Trial Design and Promotional Regulation, 2020 Budget

July 1, 2019 – Among the issues on the Food and Drug Administration’s (FDA’s) plate for the remainder of 2019 are implementing organizational changes, securing appropriations funding for 2020, modernizing clinical trial design and regulating promotional messaging, according to Nancy Bradish Myers, president, Catalyst Healthcare Consulting, who spoke at the recent Coalition for Healthcare Communication […]

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CHC News

Guest Commentary: Exploring a New Frontier in Healthcare

Guest Commentary: Exploring a New Frontier in Healthcare

June 26, 2018 — By Michael Parenti, Senior Engagement Strategist, Saatchi & Saatchi Wellness Real world evidence and data privacy regulations were among the hot topics at the Coalition for Healthcare Communication 2018 Rising Leaders Conference on Healthcare Policy. A source of much corporate concern, the European Union’s General Data Protection Regulation (GDPR) finally went […]

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CHC News

What Medical Marketers Can Expect from President Trump, Republican-led Congress

What Medical Marketers Can Expect from President Trump, Republican-led Congress

April 24, 2017 – There is no doubt that the Trump administration is likely to change health policy, but the questions that remain to be answered are exactly what those changes will be and how they will affect healthcare communication. If you want predictions and insight from a distinguished panel of FDA and policy experts, […]

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